US5672168A - Laparoscopic access port for surgical instruments or the hand - Google Patents

Abstract

A flexible, fluid-tight envelope provides access for a hand and surgical instruments through a body tissue incision while maintaining insufflation pressure or a pneumoperitoneum within the body. The envelope is transparent and has an interior volume with opposite proximal and distal ends. A first opening in the envelope at the proximal end adjoins the incision in the body tissue and is secured and sealed to the body tissue. The second opening at the envelope distal end is provided with a closure member that seals closed the second opening on itself or around the forearm of a surgeon or a surgical instrument inserted into the interior volume of the envelope. An access port is provided at the first opening in the envelope. The access port includes a housing containing a valve element that is selectively opened and closed to provide access to the tissue incision while maintaining insufflation pressure in the body cavity.

Description

This is a continuation-in-part of application Ser. No. 08/319,986; filed on Oct. 7, 1994, now U.S. Pat. No. 5,653,700.

BACKGROUND OF THE INVENTION

(1) Field of the Invention

The present invention pertains to an apparatus employed as an access port in minimally invasive surgery that enables the insertion of instruments or the hand through a small incision in body tissue while maintaining the insufflation pressure within a body cavity.

(2) Description of the Related Art

Minimally, invasive surgery, such as laparoscopy, despite its beneficial aspects, has some disadvantages. Surgery of this type involving the use of surgical instruments manipulated through trocars or cannula inserted through body tissue to a surgery site within a body cavity requires a great deal of manual dexterity and hand-eye coordination of the surgeon. Many years of practice are required before the surgeon develops a comfortable level of agility in manipulating surgical instruments inserted through trocars to the surgical site while observing the movements of the instruments through a laparoscope. Until this level of familiarity with surgery techniques is developed by the surgeon, minimally invasive surgery requires significantly more of the surgeon's time than would the same operation being performed in an open incision of the body.

Additionally, the need to maintain a pneumoperitoneum or insufflation pressure within the body cavity at the surgery site while instruments are removed from and inserted through trocars during surgery increases the time required for performing an operation by minimally invasive surgery over that required for performing the same operation through an open incision in the body.

It is an object of the present invention to provide a surgical apparatus and its method of use that assist the surgeon in performing minimally invasive surgery by providing an access port through body tissue to a body cavity at the surgery site which enables insertion of surgical instruments or the surgeon's hand through the access port while maintaining the insufflation pressure or pneumoperitoneum within the body cavity.

SUMMARY OF THE INVENTION

The surgical apparatus of the present invention is basically comprised of a flexible, fluid-tight envelope having a hollow interior and first and second openings at opposite proximal and distal ends of the envelope. In the preferred embodiment, the envelope is transparent. An access port, comprised of a pair of tubular collars in one embodiment, is secured to the opening at the proximal end of the envelope. The collars have coaxial interior bores and are connected to each other for relative rotation. The collars are provided with means for securing the collars to body tissue with the interior bores of the collars adjoining an incision through the tissue.

The distal end of the envelope is provided with means for selectively closing and sealing the second opening, or for opening the second opening to enable insertion of an instrument or the surgeon's hand into the envelope interior. With an instrument or the surgeon's hand inserted through the second opening, the means for sealing the opening is then secured around the envelope distal end and the instrument or hand to prevent the escape of insufflation pressure from the body cavity through the incision and the envelope. Several means of sealing closed the second opening of the envelope are provided including a slit second opening in the resilient material of the envelope that closes the opening in its at rest condition and is opened by stretching the material of the envelope. Various types of bands including elastic cords, strips containing malleable wire, and strips of hook and loop fastener material such as Velcro® are also secured around the distal end of the envelope to close and seal the envelope second opening.

Various embodiments of the concentric collars at the envelope proximal end are also employed in sealingly securing the envelope to the body tissue adjoining the tissue incision. These embodiments include a tapered portion of one of the collars which is wedged into the tissue incision to provide the sealed connection of the envelope to the tissue. A further embodiment employs an annular rim on one of the collars which is inserted through the incision to underlie the body tissue surrounding the incision. A panel having a circular center opening is then positioned over the collar and against the exterior of the body tissue to sandwich the tissue between the collar rim and the panel and thereby provide the sealed connection of the collars to the body tissue with the collars' interior bores adjoining the tissue incision. The embodiments of the collars are constructed of flexible plastic material that enables the collars to be clamped closed by a conventional grasper or forcep, thereby sealing closed the interior bores of the collars and enabling substitution of various embodiments of the envelope on the collars. A further embodiment of the collars is provided with a removable cap that closes over the collar interior bore sealing it closed.

In additional embodiments of the access port, the access port is comprised of a closure housing having an access opening extending through the housing that provides access to the incision surrounded by the housing. A valve element is provided on the housing that is selectively opened to provide access to the incision through the housing access opening, and closed preventing access to the incision through the access opening and maintaining the insufflation pressure within the body cavity. Various embodiments of the valve element are employed in the closure housing. These embodiments include a tethered plug that seats within the access opening to seal closed the opening, a sliding gate having an inlet opening that is aligned with the access opening in one position of the gate and displaced from the access opening in a second position of the gate, a compressible, resilient annular ring that has an inlet opening that is constricted closed when the ring is compressed and resiliently opens when the compression on the ring is relieved, and an iris valve comprised of a tubular sleeve that is twisted to constrict the sleeve to its closed position blocking the access opening of the closure housing. In each of these embodiments of the closure housing, various different embodiments of the envelope are employed.

One embodiment of the envelope has a general Y-shaped configuration with three projecting arms including one proximal arm and two distal arms. The proximal arm is provided with the first opening secured to the pair of collars and the two distal arms are provided with second and third openings and means on the distal arms for closing their openings as in the previously described embodiment of the envelope.

Further embodiments of the envelope have a tubular sleeve configuration with a first end of the sleeve secured around the exterior of the access port housing. The opposite end of the envelope sleeve is provided with one or more openings for insertion of the surgeon's hand and/or a surgical instrument into the envelope. Various mechanisms are provided for securing the envelope opening around the arm of the surgeon. In a further embodiment, the envelope is formed as an inverted glove having five fingers that depend into the interior volume of the envelope. The surgeon's fingers are inserted into the fingers in order to manipulate a surgical instrument contained in the interior of the envelope. A still further embodiment of the envelope sleeve employs a suction ring that is secured to the body tissue around the access port housing.

In use of each of the embodiments of the invention, an incision is made in the body tissue and the access port is secured to the body tissue with the center bore of the access port adjoining the tissue incision. The valve element of the access port housing is closed and the second opening of the envelope is sealed closed. The body cavity at the site of the surgery to be performed is then insufflated. The sealed connection of the access port to the body adjoining the incision and the sealed closure of the envelope second opening maintains the insufflation pressure within the body cavity while providing an access port for insertion of instruments or the surgeon's hand into the body cavity.

Insertion of an instrument or the surgeon's hand into the body cavity is accomplished by releasing the sealed closure of the envelope second opening and inserting the instrument or hand into the envelope interior through the second opening. The second opening is then again sealed closed around the instrument or forearm of the hand inserted into the envelope. The instrument or hand may then be inserted through the interior bore of the access port secured to the body with the sealed closure of the second opening around the instrument or hand maintaining the insufflation pressure within the body cavity. Alternatively, the valve element of the access port may be closed around the instrument or hand to maintain the pressure in the body cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

Further objects and features of the present invention are revealed in the following detailed description of the preferred embodiment of the invention and in the drawing figures wherein:

FIG. 1 shows a first embodiment of the invention in its operative position sealed to an incision made in body tissue and projecting into a body cavity;

FIG. 2 is a partial, in-section view of the embodiment of FIG. 1;

FIG. 3 is an in-section view of a collar of the FIG. 1 embodiment clamped closed;

FIG. 4 is a perspective view of a second embodiment of one of the collars of the invention;

FIG. 5 is a cross section of the collar of FIG. 4;

FIG. 6 is a cross section of the collar of FIG. 4 showing the collar clamped closed;

FIGS. 7 and 8 show a variant embodiment of the collar of FIG. 4;

FIGS. 9 and 10 show a further embodiment of the envelope of the invention;

FIGS. 11 and 12 show a further embodiment of the envelope of the invention;

FIGS. 13 and 14 show a further embodiment of the envelope of the invention;

FIGS. 15-17 show a further embodiment of the envelope of the invention;

FIGS. 18-20 show a further embodiment of the envelope of the invention;

FIGS. 21, 22 and 23A-23D show further embodiments of the envelope of the invention;

FIGS. 24 and 25 show a further embodiment of the invention;

FIG. 26 shows a further embodiment of the invention;

FIG. 27 shows the access port housing with an annular valve element;

FIG. 28 shows the access port housing with a gate valve and an inverted glove envelope;

FIG. 29 shows the access port housing with a plug valve and an attached envelope having two openings;

FIG. 30 shows the access port housing with an iris valve; and

FIGS. 31 and 32 show details of the construction of the iris valve.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

A first embodiment of the apparatus of the invention is shown in FIG. 1 of the drawing figures. In this embodiment the access port housing is generally comprised of afirst collar 2, a second collar 4, and a flexible, fluid-tight envelope 6. In the preferred embodiment of the invention, the three primary component parts set forth above are all constructed of flexible, resilient plastic materials. However, it should be understood that the apparatus of the invention may be constructed of various different types of materials acceptable for use in surgical instruments. Furthermore, the relative dimensions of the component parts of the invention shown in the drawing figures are illustrative only and should not be interpreted as limiting. The apparatus of the invention can be constructed in various different sizes without departing from the intended scope of the invention.

Preferably, the material of theenvelope 6 is also transparent to enable the surgeon to observe the manipulation of an instrument or the surgeon's hand in the envelope. For example, the envelope could be formed from two overlapping layers of urethane film that are heat sealed together at their edges. Other equivalent materials and methods of construction may be employed. Theenvelope 6 has a general Y-shaped configuration with afirst arm 8 at a proximal end of the envelope and second 10 and third 12 arms at the opposite distal end of the envelope. Afirst opening 14 is provided at the end of the envelopefirst arm 8 and the second collar 4 is received in the first opening. The second collar 4 and the envelope first arm are permanently secured together providing a sealed connection between the collar and envelope. Alternatively, the envelope first arm could overlap the top of the collar and be secured thereto by an elastic band or a length of suture tied around the arm and collar. The ends of the second andthird arms 10, 12 are also provided with respective second 16 and third 18 openings therethrough. Means are provided at the ends of the second andthird arms 10, 12 for selectively closing and sealing the respective second andthird openings 16, 18. The manner of closing the second and third openings will be described in more detail with reference to later embodiments. The closures at the second andthird openings 16, 18 enable these openings to be closed and sealed around surgical instruments such as theforceps 20 shown in FIG. 1. Alternatively, in a larger version of the apparatus shown in FIG. 1, the surgeon's hand and forearm can be inserted through thesecond opening 16 and the surgical instrument inserted into theenvelope interior 22 through thethird opening 18 to be grasped by the surgeon within the envelope. Thesecond opening 16 may then be secured around the forearm of the surgeon and thethird opening 18 closed and sealed to prevent the escape of insufflation pressure through the second and third openings in use of the apparatus.

The second collar 4 has a cylindrical configuration with a hollow, cylindrical interior bore extending therethrough. The interior bore 24 of the collar communicates with theinterior volume 22 of the envelope. Opposite its connection to theenvelope 6, the second collar has anannular flange 26 that extends around its exterior surface.

Thefirst collar 2 is formed of two sections, afirst section 28 having a cylindrical configuration and asecond section 30 having a tapering configuration. Thefirst section 28 has a cylindrical interior bore 32 with anannular groove 34 formed therein. Theannular groove 34 is dimensioned to receive theannular flange 26 of the second collar, thereby providing a sealed rotatable connection between the first and second collars. As seen in FIG. 1, thesecond section 30 is formed as a skin screw which screws into and forms a seal of the access port housing attaching it to the incision in the skin. The section has a tapering interior bore 36 and a tapering exterior surface over which extends ahelical thread 38. The threads are screwed into an incision in the skin tissue to sealingly attach the access port over the incision. The first collarsecond section 30 tapers to an access opening 40 that provides access from the envelopeinterior volume 22 through the interior bores of the first andsecond collars 2, 4.

Referring to FIG. 1, in use of this first embodiment of the apparatus of the invention, anincision 42 is first made throughbody tissue 44. Thefirst collar 2 is then secured in the incision by first inserting the taperedsection 30 of the collar into theincision 42 and rotating the collar, causing thehelical thread 38 to pull thecollar 2 further into the incision. Theincision 42 in thebody tissue 44 is stretched around the exterior of thefirst collar 2 as the collar is turned and effectively screwed into the incision. The snug fit of the first collar taperedsection 30 in theincision 42 secures the apparatus to the body tissue and seals the connection of the apparatus to the tissue. Alternatively, the first collar, without the skin screw, may be secured to the body tissue by adhesive tape, or may be sutured to the tissue. Thefirst collar 2 may be provided with a cannula extension (not shown) from itsaccess opening 40 to reach through all skin layers. Thefirst collar 2 may be secured to thetissue 44 by its being wedged in theincision 42 with the second collar 4 andenvelope 6 attached, or with the second collar and envelope removed. In the later case, the flexibility and resiliency of the first and second collars enables the second collar 4 to be later attached to thefirst collar 2 inserting theannular flange 26 of the second collar into theannular groove 34 of the first collar. The second andthird openings 16, 18 of theenvelope 6 are closed to seal the envelopeinterior volume 22. If so desired, an instrument such as theforcep 20 may first be inserted into the envelope interior through one of the first orsecond openings 16, 18 and then positioned in the envelope with each of itshandles 46, 48 projecting through the first and second openings. The first and second openings are then sealed closed around the handles of the forcep.

Following the setup of the apparatus of the invention described above, insufflation pressure is then supplied to thebody cavity 50. The insufflation pressure passes through the incision and also inflates the envelope. If it is later necessary to remove theforceps 20 or theenvelope 6 for its replacement with another embodiment of envelope to be described later, the resilient material of the first andsecond collars 2, 4 enable the collars to be clamped closed with thejaws 52 of a surgical clamp as illustrated in FIG. 3. This seals closed the access port provided by the apparatus of the invention maintaining the insufflation pressure while the envelope is replaced on thefirst collar 2. Alternatively, the access port housing could be provided with a valve assembly, several embodiments of which will be described later.

Because insufflation pressure is low, typically 10 mm of mercury (Hg), various different types of valve assemblies may be employed in the first collar bore to maintain insufflation pressure in the body cavity. For example, an inflatable toroid-shaped balloon which closes at its inside diameter when inflated may be employed as the valve. Also, a foam disk having a center aperture which closes due to the resiliency of the foam may also be employed as the valve. In both examples, the flexibility of the balloon or foam allow insertion of the hand and/or instruments through the center opening. The resiliency of the balloon or foam causes the center opening to seal around the hand or instrument inserted through the opening, and causes the opening to seal closed once the hand or instrument is removed. Various other types of value structures may also be employed.

FIG. 4 shows an alternative to thefirst collar 2 of the apparatus of FIGS. 1-3. In FIG. 4, thefirst collar 56 again has a cylindrical configuration with a cylindrical interior bore 58 having anannular groove 60 dimensioned to receive theannular flange 26 of the second collar 4 of the apparatus of FIGS. 1-3. However, instead of a tapered section of a collar, this embodiment of the first collar has anannular rim 62 adjacent itsaccess opening 64. Acircular panel 66 having a circular center opening 68 is positioned over thecollar 56 with the collar extending in a tight, friction fit through thepanel opening 68. Together, theannular rim 62 andpanel 66 secure this embodiment of thefirst collar 56 to the body tissue with the collar extending through the incision in the tissue.

In use of the embodiment of FIGS. 4-6, the flexible resiliency of the material of a collar enables thecollar rim 62 to be deformed and inserted through asmall incision 70 made in thebody tissue 72. The resiliency of the collar enables it to expand once inserted through theincision 70 so that the incision is stretched around the periphery of thecollar 56 and theannular rim 62 extends beneath the body tissue surrounding the incision. Thepanel 66 is then positioned over thecollar 56 with the collar inserted through thepanel opening 68. With the panel pushed down over the collar, the tight-friction fit of thepanel 66 around the collar secures the collar to thebody tissue 72 and seals the incision between thecollar rim 62 and thepanel 66. With the collar in place, the second collar 4 andenvelope 6 may then be attached to the first collar in preparation for use as described earlier with reference to the first embodiment.

Like the first collar of the first embodiment, the first collar embodiment of FIGS. 4-6 may also be sealed closed by crimping the collar between thejaws 52 of a surgical grasper as illustrated in FIG. 6, thereby sealing closed the collar interior bore 58 and maintaining the insufflation pressure in the body cavity when the envelope is removed from the collar.

Alternatively, the first collar may be provided with a sealingcap 76 as shown in FIGS. 7 and 8. Thecap 76 is connected by aflexible tether 78 to thecollar 56. Thecap 76 has anannular flange 80 around its periphery that is dimensioned to fit theannular groove 60 of the first collar with the cap inserted into the collar interior bore, thereby sealing closed the interior bore of the collar.

FIGS. 9-23 show various embodiments of the envelope, all of which may be employed with the first described embodiment of thefirst collar 2 shown in FIGS. 1-3 or the second described embodiment of thefirst collar 56 shown in FIGS. 4-8.

The embodiment of theenvelope 84 shown in FIGS. 9 and 10 does not have the Y-shaped configuration of the first described embodiment of the envelope. Theenvelope 84 has opposite proximal 86 and distal 88 ends. The envelopeproximal end 86 has afirst opening 90 that is secured to a second collar 4 identical to the second collar of the first described embodiment. The connection between theenvelope 84 and the second collar 4 is also identical to that of the first described embodiment. The material of theenvelope 84 is transparent, flexible and fluid-tight as the first described envelope. However, this embodiment of the envelope employs a material that has resiliency enabling the material to be stretched from its at-rest configuration shown in FIG. 9.

Thesecond opening 92 at the envelopedistal end 88 is formed as a slit opening. In the at-rest condition of the envelope, thesecond opening 92 is closed. The resiliency of the envelope material is sufficient to maintain the second opening closed in its at-rest condition and prevent leakage of insufflation pressure, typically 10 mm of mercury (Hg), through the slit opening. A pair ofears 94 project from the envelope on opposite sides of thesecond opening 92. Each of theears 94 has ahole 96 therethrough that can be engaged by a spreading tool to move the ears away from each other. Movement of theears 94 away from each other stretches the slit opening 92 of the envelope open, enabling the insertion of instruments, such as the intermediate length of thesurgical grasper 98 shown in FIG. 10, through the opening. The resiliency of the envelope material causes the slit opening 92 to close and seal around thegrasper 98 when theears 94 are released, thereby maintaining the insufflation pressure.

As in the first embodiment of the invention, the second collar 4 at the proximal end of theenvelope 84 is provided with anannular flange 26 that engages in the annular groove of the first collar forming the sealed, rotating connection between the first collar and theenvelope 84.

FIGS. 11 and 12 show an embodiment of theenvelope 102 similar to the previously described embodiment of theenvelope 84 of FIGS. 9 and 10. The difference between the embodiment of FIGS. 9 and 10 and that of FIGS. 11 and 12 is that the slit opening and ears of the previous embodiment are replaced by anelastic band 104 that surrounds thesecond opening 106 at the distal end of the FIG. 11 and 12 envelope embodiment. The remaining construction of theenvelope 102 and second collar 4 remains the same as previously described embodiments. In the embodiment of FIGS. 11 and 12, theelastic band 104 is stretched open to enable insertion of an instrument, such as theforceps 108, into the envelopesecond opening 102. Theband 104 is then allowed to contract around theforceps 108 near the hinge point or box lock to essentially seal thesecond opening 106 around the forceps and maintain insufflation pressure. As shown in FIG. 12, the flexibility of the envelope material enables the envelope to be folded back in through its interior when reaching into the incision with the forceps.

In the embodiment of the envelope shown in FIGS. 13 and 14, thesecond collar 112 varies only slightly from the second collar of the previously described embodiments in that it has anannular groove 114 formed around its exterior surface. The remaining construction of the second collar and the manner in which it connects to the first collar for relative rotation therewith remains the same.

Various embodiments of the envelope may be removably attached to the embodiment of thesecond collar 112 shown in FIG. 13. Theenvelope 116 shown in FIGS. 13 and 14 again has the general Y-shaped configuration of the first described embodiment including theproximal arm 18 and twodistal arms 120, 122. Theproximal arm 118 has afirst opening 124 to the interior volume of the envelope and thedistal arms 120, 122 have second andthird openings 126, 128 to the envelope interior. Connected to the proximal and distal arms adjacent their openings are flexible bands, in this embodiment lengths ofelastic cord 130 secured adjacent the openings by sections ofadhesive tape 132.

In securing theproximal arm 118 to thesecond collar 112, the collar is inserted through thefirst opening 124 of the arm and the length ofcord 130 is positioned adjacent the collarexternal groove 114. The length of cord is then tightly bound around the envelopeproximal arm 118 overlying the collarexterior groove 114 securely connecting the proximal arm of the envelope to the collar. The connection of the envelope arm to the collar in this manner provides a sufficient seal between the arm and collar to maintain insufflation pressure. The second andthird openings 126, 128 of thedistal arms 120, 122 are sealed closed in the same manner. The second and third openings may be sealed closed upon themselves, or may be sealed closed around the forearm of the surgeon or around a surgical instrument by binding thecords 130 around the distal arms in the same manner as described with reference to the proximal arm of theenvelope 116.

The embodiments of the envelope shown in FIGS. 15-20 are substantially identical to that shown in FIGS. 13 and 14 except that other closure means are employed in lieu of thecord 130 employed in the FIGS. 13 and 14 embodiment.

In FIG. 15, two strips ofadhesive tape 134 are secured to each of theenvelope arms 136. A length ofmalleably metal 138, for example a length of wire, is sandwiched between the two pieces of tape. To close the openings at the ends of the two envelopedistal arms 136, the tape containing the wire is wrapped around the arm and theinstrument 140 inserted through the arm openings to securely seal the openings around the instrument as shown in FIG. 17. If an instrument is not inserted through the arm opening, the tape containing the wire is merely wrapped around the arm to seal closed the opening. The wire within the tape maintains the tape in its wrapped configuration around the envelope arm.

FIGS. 18-20 show a further embodiment in which the cords and tape of the previously described embodiments are replaced by hook and loop fasteners, for example Velcro® type fasteners. As shown in the drawing figures, each of the envelopedistal arms 146 has the backside of ahook fastener strip 148 and aloop fastener strip 150 secured thereto. Portions of the backsides of the hook and loop fastener strips are also secured together. To seal closed the arm opening around aninstrument 152 inserted through the opening, the hook and loop fasteners are wrapped around the envelope distal arm and the instrument inserted through the opening of the arm. This causes thehook strip 148 to overlap theloop strip 150 and thereby seal closed the arm opening around theinstrument 152.

Although only the envelope distal arms are shown in FIGS. 15-20, it should be understood that the tape and wire closure shown in FIGS. 15-17 and the hook and loop closure shown in FIGS. 18-20 may be employed to removably secure the proximal arm to the second collar in lieu of theelastic cord 130 disclosed in the embodiment of FIGS. 13-14. Still further, the envelope openings at the proximal and distal ends of the envelope may be sealed closed in other equivalent manners than those disclosed above.

Theenvelope 156 of the FIG. 21 embodiment is similar to the previously described Y-shaped embodiments except that itsfirst arm 158 is formed as a bellows with a plurality of pleats. The pleats formed in thefirst envelope arm 158 give it even more flexibility than the previously described embodiments and enable reaching deep into an incision with aninstrument 160 by compressing the pleats of the bellows. Expanding the pleats of the bellows enables theinstrument 160 to be withdrawn and spaced far from the incision with the expanding bellows pleats significantly increasing the interior volume of theenvelope 156. Thedistal arms 162 of the envelope are secured and sealed to the handles of theinstrument 160 in the same manner as any of the previously described embodiments. The proximal end of theenvelope 164 is secured to acollar 166 that can be releasably attached to any of the previously described embodiments of the first collar. Additionally, thecollar 166 can be secured directly to the body tissue surrounding the incision as shown in FIG. 21. The lower end of the collar is first inserted through the incision until theannular flange 168 of the collar abuts against the exterior surface of the tissue surrounding the incision. The collar may then be secured in place to the tissue incision by passing suture through the collar and the tissue surrounding the incision. Alternatively, the collar could be secured in place through the use of adhesive tape. In use of the collar in this manner, the lower end of the collar is extended to ensure that it reaches completely through the layer of skin tissue.

FIGS. 22 and 23 show a variation of the envelope of FIG. 21. In this embodiment, the envelope distal end has acircular cap 172 removable secured thereto. The cap is preferably constructed of a flexible plastic material and is provided with an interior annular groove (shown in dashed lines in FIG. 22) much the same as the annular groove provided in the first and second embodiments of thefirst collar 2, 56 described earlier. Thedistal end 174 of theenvelope 170 has anannular flange 176 formed thereon dimensioned to mate in the annular groove on the interior of thecap 172. The insertion of theannular flange 176 into the cap annular groove provides a releasable, sealed connection between the envelopeproximal end 174 and thecap 172.

Thecap 172 is also provided with a pair ofdistal arms 178. Thearms 178 are also constructed of the flexible, resilient plastic material enabling the handles of an instrument to be inserted through the interiors of the arms as illustrated in FIG. 23C.Elastic cords 180 are secured to each of thearms 178 for securing the arms closed around the instrument handles as in the previous embodiments. Other equivalents of thecords 180 may also be employed in closing thearms 178 around the instrument handles.

By providing a detachable cap on the envelope, the pleated section of the envelope does not need to be very wide. The envelope can be much narrower if the instrument can be loaded into the envelope from the top. In this way, the handle rings of the instrument do not have to fit through the envelope. (See FIG. 23). Use of this embodiment of the invention is illustrated in FIGS. 23A-23D. Theremovable cap 172 is first removed from the proximal end of theenvelope 170 exposing the envelope interior volume. Theinstrument 182 may then be inserted into the envelope. As shown in FIG. 23B, the interior volume of the envelope provides ample room for manipulation of the instrument. Thecap 172 is then positioned over the instrument's handles inserting each of the handles through thearms 178 of the cap so that they project from the arms as illustrated in FIG. 23C. Thecap 172 is then secured to the envelopedistal end 174 by inserting theannular flange 176 into the interior annular groove of the cap as explained earlier. Thecords 180 are next secured tight (e.g. by a simple half-hitch) around thearms 178 sealing the arms to the instrument handles. This embodiment of the invention is now ready for use in the same manner as the previously described embodiments.

FIGS. 24 and 25 show a further embodiment of the apparatus where the envelope of the apparatus is secured to the body tissue on the exterior surface of the tissue surrounding the incision. Referring to FIG. 24, this embodiment is comprised of anenvelope 184 having a wide circular base with a projectingannular rim 186. Therim 186 is secured to the exterior surface of thebody tissue 188 byadhesive strips 190. Alternatively, therim 186 may be secured to thetissue 188 by suturing or other equivalent means. Theenvelope 184 extends upwardly from its base and tapers toward a bellows section having a plurality ofcircular pleats 192. The tapering of the envelope gives it a general conical configuration with a larger interior volume of the envelope positioned adjacent itsannular rim 186 than the volume of the envelope adjacent thepleats 192. Thepleats 192 enhance the flexibility of the envelope allowing it to expand away from thetissue incision 194 and compress toward the incision.

Aport opening 196 passes through the side of the envelope just below thepleats 192. Theport 196 is provided for gas insufflation of the body cavity accessible through theincision 194 and the interior volume of the envelope. A similar port may be provided on the envelopes of the previously described embodiments.

Just above the plurality ofcircular pleats 192 the distal end of the envelope is formed as acylindrical sleeve 198. Positioned against the interior surface of thesleeve 198, is avalve 200 that seals closed around an instrument or a surgeon's hand inserted through the valve, or closes the center opening 202 of the valve when the instrument or hand is removed. Thevalve 200 may be a toroid of foam secured to the interior surface of thesleeve 198. The resilience of the foam enables itscenter opening 202 to expand when an instrument or the surgeon's hand is inserted through the opening, maintaining a sealed closure around the instrument or hand sufficient to maintain insufflation pressure in the body cavity and the envelope interior. Theseal 200 may also be an inflatable bladder having a toroid shape which functions in the same manner as the foam toroid seal. Additionally, the toroid foam valve and the inflatable bladder toroid valve may be friction fit in and removable from the interior of theenvelope sleeve 198. In this variation of the valve, it remains sealed around the hinge box of the surgical instrument or the surgeon's wrist as the instrument or wrist are removed from the interior of theenvelope sleeve 198. In use of a valve of this type, the resilient material of theenvelope 184 must be clamped closed by a surgical clamp as in previously described embodiments in order to maintain insufflation pressure in the body cavity as the instrument or wrist with attached seal are removed from the interior of theinstrument sleeve 198. On reinsertion of the instrument or wrist with the attached seal back into the envelope interior with the toroid seal positioned in theenvelope sleeve 198 interior, the clamp sealing closed the envelope may then be removed to permit access for the instrument through thetissue incision 194. The repositioned seal in theenvelope sleeve 198 maintains insufflation pressure in the body cavity and the envelope interior.

FIG. 26 shows a still further embodiment of the apparatus of the invention. The embodiment of FIG. 26 is basically comprised of theflexible envelope 208 similar to previously described embodiments of the envelope, secured to acollar 210 which is also similar to previously described embodiments of the collar in FIGS. 1-23. Theenvelope 208 is shown permanently secured to thecollar 210. However, the proximal end of theenvelope 212 may be secured to thecollar 210 in a variety of different manners such as the previously described embodiments. The upper end of thecollar 210 may be inserted into the opening at the envelopeproximal end 212 and the envelope secured around the collar by a cord such as a length of elastic tubing or a length of suture. The proximal end of the envelope may also be secured to the collar in other equivalent manners.

Thecollar 210 is similar to previously described embodiments of the second collar. It may also be releasably connected to a first collar such as that shown in FIGS. 1-4 and 5-8. Alternatively, thelower end 216 of the collar may be inserted directly into the tissue incision 218 as shown in FIG. 26. The incision 218 made through thebody tissue 220 would be smaller than the periphery of the collarlower end 216 so that the tissue surrounding the incision is stretched to fit around the collar. Thecollar 210 would then be secured in place on thebody tissue 220 and extending into the incision 218 by a plurality ofsutures 222 passing through the tissue and the collar around the periphery of the collar. Alternatively, the collar could be secured in place extending into the incision by adhesive tape or other equivalent means.

Theenvelope 208 of the FIG. 26 embodiment differs from previously described embodiments in that asecond opening 224 and athird opening 226 are provided in the envelope and are sealed closed by opposed tongue and grooveflexible strips 228, 230, of the type employed on Ziploc® brand plastic bags. The opposedtongue 228 and groove 230 flexible strips, shown opened at thesecond opening 224 and closed at thethird opening 226, provide two closures in theenvelope 208 that are easily opened and closed as needed. Furthermore, in their closed positions they provide a sufficient seal to maintain insufflation pressure in the body cavity and the envelope interior. Providing the two tongue and groove closures at the second 224 and third 226 openings enables the surgeon's hand to be inserted through one opening and the opening sealed closed around the surgeon's wrist either by closing the tongue and groove strips or securing the envelope adjacent the second opening closed around the surgeon's wrist with a flexible cord as employed in the previous embodiments. With the envelope secured closed around the surgeon's wrist, as different instruments are needed by the surgeon these instruments can be removed from the envelope interior and inserted into the interior where they can be grasped by the surgeon's hand through thethird opening 226.

Each of the later described embodiments of the invention is used in the same manner as the first described embodiment in providing access for a hand or instrument through a body tissue incision while maintaining insufflation pressure or a pneumoperitoneum within the body. Additionally, the apparatus of the invention may be employed by containing each of the instruments intended to be used in a minimally invasive surgical operation within their own envelope of the apparatus. The second collar 4 of each envelope would then enable the instruments, contained in their own envelope, to be quickly connected with thefirst collar 2 as needed during the course of the operation. Thefirst collar 2 would be provided with a valve structure in its interior, for example, a stricture or some other equivalent type of valve within the interior bore of the first elastomeric collar to close and seal the bore as instruments in their own envelopes are removed from and attached to the first collar. The quick connect releasable connection of the first and second collars described above may also be replaced by other known types of connections, for example, a bayonet-type connection that enable the first and second collars to be quickly connected and disconnected as desired. Furthermore, the size of the envelope can be substantially increased from that shown in the drawing figures so that several instruments needed to perform a particular operation may be contained in the one envelope. This would enable the surgeon to pick up and use the instruments contained in the envelope as needed without breaking the seal in the wall of the envelope or around the surgeon's wrist to remove instruments from the envelope or insert additional instruments into the envelope.

FIG. 27 shows a further embodiment of theaccess port housing 250 which is comprised of afirst housing member 252 and asecond housing member 254. Thefirst housing member 252 preferably has a cylindrical configuration with a cylindrical access opening 256 extending therethrough. Anannular groove 258 is formed in the interior of thefirst housing opening 256 and anannular flange 260 of askin screw 262 is received in the annular groove. The engagement of the flange in the groove secures theskin screw 262 to theaccess port housing 250. As described with reference to the embodiment of FIGS. 1-3, theskin screw 262 is turned in theincision 264 through thebody tissue 266 to secure theaccess port housing 250 to the tissue over the incision. The cylindrical interior surface of the first housing member opening 256 also hasinterior screw threads 268 formed in the interior surface of the access opening adjacent the top of the housing member. Just below the interior screw threads is anannular shoulder 270 formed in the interior surface of the opening.

Thesecond housing member 254 also has a cylindrical configuration and a cylindrical access opening 272 extending through its interior. The access opening 272 of the second member has substantially the same size diameter as the access opening 256 of the first housing member.Exterior screw threads 274 are formed on the outside of the second housing member. The exterior screw threads are complimentary to the interior screw threads of the first housing member. Aflange 276 projects beyond the exterior screw threads at the top of the second housing member. Theflange 276 preferably has a hexagonal configuration that facilitates manually turning the flange and the second housing member.

Anenvelope sleeve 278, such as any one of the previously described embodiments of the sleeve or the yet to be described embodiments, is attached to theaccess port housing 250 between the first and second housing members. Thesleeve 278 has anannular ring 280 secured at its proximal opening. Theannular ring 280 fits between the top surface of thefirst housing member 252 and the bottom surface of the secondhousing member flange 276. Theannular ring 280 is resilient and compressible, providing a sealed connection between the sleeve and the access port housing.

Anannular valve element 282 is positioned in the access opening of the access port housing between the first and second housing members. Theannular valve element 282 is constructed of a compressible, resilient material. An inlet opening 284 passes through thevalve element 282. By selectively turning thesecond housing member 254 so that it is screwed downwardly toward thefirst housing member 252, theannular valve element 282 is compressed within the access opening of the access port housing. Compressing the annular valve element between the two housing members causes the inlet opening 284 of the element to constrict, closing the inlet opening. The constricted, closed inlet opening is represented by dashed lines in FIG. 27. By turning thesecond housing member 254 so that it moves away from thefirst housing member 252, the resiliency of theannular valve element 282 causes it to resume its uncompressed configuration shown in FIG. 27, thereby opening theinlet opening 284. In this manner, theaccess port housing 250 selectively opens and closes access to thebody tissue incision 264.

FIG. 28 shows a further embodiment of theaccess port housing 290. This housing also has a cylindrical configuration with a cylindrical access opening 292 extending through the center of the housing. Anannular groove 294 is formed in the interior surface of the housing access opening and anannular flange 296 of askin screw 298 is received in the annular groove. The engagement of theannular flange 296 in theannular groove 294 secures the skin screw to the access port housing.

Agate valve element 300 is mounted in thehousing 290 and selectively opens and closes access through thehousing access opening 292. The gate valve element is a planer member having a width larger than the diameter of thehousing access opening 292. The length of the gate valve extends from a T-shapedridge 302 at its rearward end or left hand end as viewed in FIG. 28, through ahorizontal slot 304 having a rectangular cross section corresponding to the rectangular cross section of the gate valve, to amanual knob 306 at the forward end of the gate valve positioned outside the access port housing. The gate has aninlet opening 308 passing therethrough. Theinlet opening 308 is circular and of the same size as thehousing access opening 292. It is positioned on the gate so that, in the at rest position of the gate, the inlet opening is displaced from the housing access opening as shown in FIG. 28, thereby blocking access to the incision through the access opening. The T-shapedridge 302 of the gate is positioned within arectangular chamber 310 in the access port housing. The chamber is dimensioned sufficiently large to enable the T-shapedridge 302 to be reciprocated through a portion of the chamber, and thereby reciprocating thegate valve 300 through thehorizontal slot 304 in the access port housing. Aspring 312 biases the gate valve to the right as viewed in FIG. 28. Thechamber 310 is sufficiently large to enable manual manipulation of theknob 306 causing the gate valve to move to the left a sufficient distance to align the cylindrical access opening 292 of the housing with the inlet opening 308 of the gate valve. Theinlet opening 308 has a diameter that matches that of the access opening 292 and when aligned with the access opening, provides access through thehousing 290 and through theskin screw 298 and the tissue incision. Releasing themanual knob 306 causes the gate valve to move to the right to its at rest position shown in FIG. 28 under the bias of thespring 312, thereby closing thehousing access opening 292.

Anannular flange 316 is provided at the top of thehousing 290 surrounding theaccess opening 292. Aflexible instrument seal 318 is positioned over the annular flange. The seal has an inwardly projectingannular flange 320 that engages underneath theannular flange 316 of the housing to securely hold the seal over thehousing access opening 292. Anopening 322 passes through the center of the instrument seal. Theopening 322 is dimensioned much smaller than the access opening 292 of the housing. Theinstrument seal 318 is constructed of a stretchable, resilient material that enables theseal opening 322 to expand when a surgical instrument is inserted through the opening. The stretching of theseal 318 around the instrument inserted through theseal opening 322 provides access through the seal while sealing around the instrument, thereby maintaining insufflation pressure in the body cavity. When the gate valve is moved to its open position to the left as viewed in FIG. 28, a surgical instrument may then be inserted through the seal opening and the housing into the tissue incision.

Anenvelope 324 similar to previously described embodiments of the envelopes is secured to the exterior of theport housing 290. The envelope has an opening at one end with an elastic,resilient ring 326 secured around the opening. Thering 326 may be an elastic band, an O ring, or other equivalent mechanism that can be employed to secure the opening of theenvelope 324 around theaccess port housing 290.

As in previous embodiments, theenvelope 324 has a general tubular, sleeve configuration except that the opposite end of the envelope from theport housing 290 does not have an opening. Theenvelope 324 is closed at its opposite end and has five inverted finger shapedappendages 328 formed in the envelope and extending into the interior volume of the envelope. Theappendages 328 are dimensioned to receive the five fingers of either hand of the surgeon therein. They enable the surgeon to manipulate an instrument within the interior volume of theenvelope 324 without requiring a second opening in the envelope that must be sealed around the surgeon's arm or the instrument as in previous embodiments of the envelope.

FIG. 29 shows a further embodiment of theaccess port housing 330 and an additional embodiment of theenvelope 332.

Theaccess port housing 330 is similar to the embodiment of the housing shown in FIG. 28. The housing also has a cylindrical configuration with askin screw 334 secured to the lower end of the housing substantially in the same manner as that of the previously described embodiment of FIG. 28. A generally cylindrical access opening 336 passes through the housing and expands as it extends from the top of the housing to the bottom of the housing. Anannular flange 338 surrounds the access opening at the top of the housing and aninstrument seal 340 is secured over the flange in the same manner as the previously described embodiment.

The FIG. 29 embodiment of theaccess port housing 330 differs from that of the FIG. 28 embodiment in that it does not include a gate valve and its related structure. Instead, theinstrument seal 340 of the FIG. 29 embodiment is provided with aplug 342 secured to the seal by atether 344. Theplug 342 is dimensioned to sealingly seat in the seal opening 346 of the instrument seal, thereby closing the seal opening and maintaining insufflation pressure in the body cavity. Theplug 342 is dimensioned sufficiently large to be easily inserted into the seal opening to close access through the access port housing, and to be manually removed from the opening providing access through the housing. Theinstrument seal 340 is constructed of flexible, resilient material that enables theseal opening 346 to stretch around an instrument inserted through the opening, thereby provided access through the opening while sealing around the instrument.

Theenvelope 332 is similar to that of the envelope embodiment shown in FIG. 26 except that theenvelope 332 has only one zip-type closure 348 at the side of the envelope intermediate its ends, and has a VELCRO® type closure 350 around the end of the envelope opposite theaccess port housing 330. As in previous embodiments, the envelope has a generally tubular, sleeve configuration. The end of the envelope opposite the VELCRO® type closure 350 is secured to acylindrical collar 352 having a radially outwardly projectingannular flange 354. Thecollar 352 extends around the opening to the envelope. Anannular cap 356 is mounted on thecollar 352 for rotation of the cap relative to the collar. The cap has a set ofthreads 358 formed in its interior surface. A complimentary set ofthreads 360 are formed around the exterior surface of theaccess port housing 330. Engagement of the threads of theannular cap 356 over thethreads 358 of the housing removably attaches the envelope to the housing.

FIGS. 30-32 show a further embodiment of theaccess port housing 362 of the invention. This embodiment of the access port housing may be employed with any embodiment of the envelope, but may also be used without an attached envelope. Theaccess port housing 362 shown in FIG. 30 is shown used with a further embodiment of theenvelope 364 that is not attached to the access port housing as will be explained.

Theaccess port housing 362 is comprised of afirst housing member 366 and asecond housing member 368. FIGS. 30, 31 and 32 show variations of the first housing member that differ only slightly from each other. In the embodiment shown in FIGS. 30 and 31, thefirst housing member 366 has a cylindrical configuration with a cylindricalinterior surface 370 and anannular flange 372 that projects radially inwardly a slight distance from the bottom of the housing member. Theflange 372 provides an abutment surface for theannular flange 374 of askin screw 376. Theskin screw 376 is employed to secure theaccess port housing 362 to the tissue incision positioned over the tissue incision. Asmall notch 378 is provided in thecylindrical sidewall 380 of the first housing member.

A first annular member is secured within thecylindrical sidewall 380 of thefirst housing member 366. The first annular member is comprised of abottom ring 382 and atop ring 384. The two rings are substantially identical to each other except that thebottom ring 382 has a projectingtab 386 and anannular groove 388 in its top surface. The top ring has a projectingannular ridge 390 that is dimensioned to be received in theannular groove 388 of the bottom ring.

A tubular, flexible andresilient sleeve 392 is secured to the first annular member. The sleeve has opposite first and second ends. Thefirst end 394 is stretched between thebottom ring 382 andtop ring 384 of the first annular member and is secured therebetween with the annular projectingridge 390 inserted into theannular groove 388 of the members. The first end of thesleeve 394 may be secured between the bottom ring and top ring of the first annular member by adhesives or other equivalent methods. The first annular member is then inserted into thecylindrical sidewall 380 of thefirst housing member 366 with the projectingtab 386 engaged in thenotch 378 of the first housing member. The engagement of the tab in the notch secures the first annular member stationary relative to thefirst housing member 366.

Thesecond housing member 368 is similar to the first housing member in that it has a cylindrical configuration substantially the same size as that as the first housing member. The second housing member has acylindrical sidewall 396 with a cylindricalinterior surface 398. Anannular flange 400 projects inwardly from thecylindrical sidewall 396 at the top of the second housing member. A pair ofarcuate notches 402 are formed in thecylindrical sidewall 396 opposite theannular flange 400. In the preferred embodiment, thearcuate notches 302 are positioned directly opposite each other and extend through 120° of the circumference of the cylindrical sidewall. Within the second housing member, where the cylindrical sidewallinterior surface 398 joins the interior surface of theannular flange 400, acircular recess 404 is formed. An O-ring 406 is received in thecircular recess 404.

A second annular member is mounted for rotation within thesecond housing member 368. The second annular member is comprised of abottom ring 408 and atop ring 410. The bottom ring and top ring of the second annular member are similar to the bottom ring and top ring of the first annular member, except that thetop ring 410 has a pair of projectingtabs 412 on opposite sides of the ring. Thetop ring 410 also has anannular groove 414 formed in its underside. Thebottom ring 408 has anannular ridge 416 formed on its top surface that is dimensioned to be received in theannular groove 414 of the top ring.

Thesecond end 418 of thetubular sleeve 392 is stretched between the second annularmember top ring 410 andbottom ring 408 and is secured therebetween by the engagement of the annular projectingridge 416 in theannular groove 414. The top and bottom rings of a second annular member may be secured together by adhesives or other equivalent methods, thereby securing the second end of the tubular sleeve between the two rings. The top and bottom rings 410, 408 of the second annular member are assembled into thecylindrical sidewall 396 of thesecond housing member 368 with the opposed projectingtabs 412 positioned within thearcuate notches 402. The top surface of thetop ring 410 engages against the O-ring 406 forming a seal between thesecond housing member 368 and the second annular member. This positioning of the second annular member in the second housing member enables the second annular member to be rotated through 120 degrees relative to the second housing member.

Thesecond housing member 368 is assembled to thefirst housing member 366 as shown in FIGS. 30 and 32. The two housing members may be secured together by adhesives, mechanical fasteners such as screws, or by other equivalent methods. With the first and second housing members assemble together, the first annular member formed by thetop ring 384 andbottom ring 382 is held stationary within theaccess port housing 362. The second annular member formed by thetop ring 410 and thebottom ring 408 is capable of being rotated through 120° between first and second positions of the second annular member relative to the access port housing. The first position of the second annular member relative to the access port housing is shown in FIG. 30. In this position, the interior of thetubular sleeve 392 forms an inlet opening through the access port housing providing access from the exterior of the housing through the tissue incision by way of theskin screw 376. When the second annular member comprised of thetop ring 410 andbottom ring 408 is rotated to its second position relative to the access port housing, thetubular sleeve 392 is twisted about its center inlet opening and closes the inlet opening. Alternatively, with an object inserted through the inlet opening of theaccess port housing 362, when the second annular member, comprised of thetop ring 410 andbottom ring 408, is twisted to its second relative position to the housing, thetubular sleeve 392 is twisted around the object inserted through the inlet opening, thereby constricting the sleeve around the object and sealing the sleeve around the object. In this manner, the valve element formed by the first and second annular members of theaccess port housing 362 selectively opens and closes access through the tissue incision by way of the inlet opening.

The embodiment of theenvelope 364 shown in FIG. 30 is the same as previously described embodiments of the envelope except for the manner in which it is secured around the tissue incision. In the embodiment of FIG. 30, theenvelope 364 is provided with anannular suction ring 420 that surrounds theaccess port housing 362. The suction ring has anannular groove 422 that extends around its underside. Asuction stem 424 is secured to theannular ring 420 and communicates with theannular groove 422. In use, theannular suction ring 420 is positioned on the body tissue surrounding the incision as shown in FIG. 30. A source of vacuum pressure is then communicated with thesuction stem 424, creating a suction vacuum pressure within theannular groove 422 of the ring. The suction vacuum pressure securely holds theannular ring 420 to the tissue surface, thereby securing theenvelope 364 to the tissue surface.

As stated earlier, the embodiment of the access port housing shown in FIG. 32 differs from that of FIGS. 30 and 31 only in the construction of the first housing member. The remaining construction of the access port housing shown in FIG. 32 is the same as that shown in FIG. 1. Thefirst housing member 428 of this embodiment does not employ theskin screw 376 to securely attach the access port housing over the incision. Therefore, thecylindrical sidewalls 430 of this first housing member need not be as large as that of the embodiment of FIG. 31 because they do not require receiving theannular flange 374 of the skin screw therein. Instead, the exterior of thefirst housing member 428 is provided with a pair of oppositely projectingarms 432.Notches 434 are provided in the top surfaces of the arms. In securing this embodiment of the access port housing to the body tissue surrounding the incision, the projectingarms 432 are sutured to the body tissue with suture being looped through thenotches 434 of each of the arms. In this manner, thefirst housing member 428 of this embodiment of the access port housing is securely held over the tissue incision.

Although the invention has been described by reference to specific embodiments, it should be understood that other variations and adaptations of the invention can be made without departing from the intended scope of the invention defined by the following claims.

Claims (13)

What is claimed is:

1. A surgical apparatus providing hand and surgical instrument access through a body tissue incision and providing a sealing closure of the incision, the apparatus comprising:

an access port housing having a surface configured to be placed on the body tissue over the incision, the housing having an exterior dimensioned sufficiently large to surround the incision, the housing having an access opening extending therethrough that provides access to the incision surrounded by the housing from outside the housing, and a valve element on the housing that is selectively opened providing access to the incision through the access opening and closed preventing access to the incision through the access opening;

the valve element on the housing is manually operable from outside the housing to selectively open and close access to the incision through the access opening; and,

the valve element is an annular element of compressible, resilient material with an inlet opening extending therethrough;

the housing is comprised of first and second members attached together for relative, selective movement of the first member toward and away from the second member, and the valve element is positioned between the first and second member and is compressed, constricting the inlet opening when the first member moves toward the second member, and the valve element resiliently expands opening the constricted inlet opening when the first member is moved away from the second member.

2. The apparatus of claim 1, wherein:

a flexible, fluid tight envelope having an interior volume is secured to the exterior of the housing, the envelope has an exterior and an opening in the envelope that enables insertion of an object into the envelope interior from the envelope exterior through the envelope opening.

3. The apparatus of claim 2, wherein:

the envelope has a plurality of finger cavities formed in the envelope that are dimensioned to receive fingers of a hand in the finger cavities from outside the envelope.

4. A surgical apparatus providing hand and surgical instrument access through a body tissue incision and providing a sealing closure of the incision, the apparatus comprising:

an access port housing having a surface configured to be placed on the body tissue over the incision, the housing having an exterior dimensioned sufficiently large to surround the incision, the housing having an access opening extending therethrough that provides access to the incision surrounded by the housing from outside the housing, and a valve element on the housing that is selectively opened providing access to the incision through the access opening and closed preventing access to the incision through the access opening;

the valve element on the housing is manually operable from outside the housing to selectively open and close access to the incision through the access opening; and,

the housing has first and second annular members mounted for rotation relative to each other between first and second positions; and

the valve element is a flexible, tubular sleeve having a length with opposite first and second ends, the first end of the sleeve is attached to the first annular member and the second end of the sleeve is attached to the second annular member, the sleeve has an interior bore dimension to permit insertion of a surgeon's hand and arm through the bore with the first and second annular members in their first relative position, and the length of the sleeve twists constricting the bore around the surgeon's arm inserted through the bore sealing the housing access opening closed around the arm when the first and second annular members are moved from their first relative positions toward their second relative positions.

5. The apparatus of claim 4, wherein:

a flexible, fluid tight envelope having an interior volume is secured to the exterior of the housing, the envelope has an exterior and an opening in the envelope that enables insertion of an object into the envelope interior from the envelope exterior through the envelope opening.

6. The apparatus of claim 5, wherein:

the envelope has a plurality of finger cavities formed in the envelope that are dimensioned to receive fingers of a hand in the finger cavities from outside the envelope.

7. A surgical apparatus providing hand and surgical instrument access through a body tissue incision and providing a sealing closure of the incision, the apparatus comprising:

an access port housing having a surface configured to be placed on the body tissue over the incision, the housing having an exterior dimensioned sufficiently large to surround the incision, the housing having an access opening extending therethrough that provides access to the incision surrounded by the housing from outside the housing, and a valve element on the housing that is selectively opened providing access to the incision through the access opening and closed preventing access to the incision through the access opening;

the valve element on the housing is manually operable from outside the housing to selectively open and close access to the incision through the access opening;

the housing has first and second annular members mounted for rotation relative to each other between first and second positions; and,

the valve element is a flexible, tubular sleeve having a length with opposite first and second ends, the first end of the sleeve is attached to the first annular member and the second end of the sleeve is attached to the second annular member, the sleeve has an interior bore dimensioned to permit access to the incision through the bore with the first and second annular members in their first relative position, and the length of the sleeve twists constricting and closing the bore preventing access to the incision through the bore with the first and second annular members moved to their second relative position.

8. The apparatus of claim 7, wherein:

a flexible, fluid tight envelope having an interior volume is secured to the exterior of the housing, the envelope has an exterior and an opening in the envelope that enables insertion of an object into the envelope interior from the envelope exterior through the envelope opening.

9. The apparatus of claim 8, wherein:

the envelope has a plurality of finger cavities formed in the envelope that are dimensioned to receive fingers of a hand in the finger cavities from outside the envelope.

10. A surgical apparatus providing hand and surgical instrument access through a body tissue incision and providing a sealing closure of the incision, the apparatus comprising:

an access port housing having a surface configured to be placed on the body tissue over the incision, the housing having an exterior dimensioned sufficiently large to surround the incision, the housing having an access opening extending therethrough that provides access to the incision surrounded by the housing from outside the housing, and a valve element on the housing that is selectively opened providing access to the incision through the access opening and closed preventing access to the incision through the access opening;

the valve element on the housing is manually operable from outside the housing to selectively open and close access to the incision through the access opening; and,

the valve element has a gate mounted on the housing for movement between first and second positions of the gate relative to the housing, and the gate has an inlet opening positioned on the gate so that the gate blocks the access opening of the housing when the gate is in the first position, and the inlet opening is aligned with the access opening when the gate is in the second position.

11. The apparatus of claim 10, wherein:

the gate is biased toward the first position.

12. The apparatus of claim 10, wherein:

a flexible, fluid tight envelope having an interior volume is secured to the exterior of the housing, the envelope has an exterior and an opening in the envelope that enables insertion of an object into the envelope interior from the envelope exterior through the envelope opening.

13. The apparatus of claim 12, wherein:

the envelope has a plurality of finger cavities formed in the envelope that are dimensioned to receive fingers of a hand in the finger cavities from outside the envelope.

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